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Query: UMLS:C0019693 (HIV)
 170,526 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The efficacy of post-exposure prophylaxis (PEP) in treating non-occupational HIV exposure is not yet known, primarily due to the inability to conduct a double-blind, randomized study. Clinical monkey trials have shown that treatment given within 24 hours after exposure can protect the animals from SIV. However, the only data for humans is from a 1995 case-control study of exposed health care workers, and from ACTG 076, a clinical trial that showed that AZT could reduce perinatal HIV transmission by two-thirds. To that end, the Centers for Disease Control and Prevention (CDC) hopes to collect more data from a registry through which it monitors more than 2,000 exposed health care workers who have received treatment.
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PMID:Scientific basis for PEP rests in animal trials. 1136 81

Results of the ACTG 300 clinical trial show that infants and children with symptomatic HIV infection are treated more successfully when given AZT plus either 3TC or ddI, than with ddI alone. This combination can slow disease progression and reduce the risk of death. The most noticeable results were seen in patients under three years of age. Two protease inhibitors, nelfinavir and ritonavir, have also been approved for treating HIV infection in children, and are currently in combination trials.
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PMID:Combination therapies improve outlook for children with HIV disease. 1136 6

ACTG 333 tested the effectiveness of other protease inhibitors in patients who had been on saquinavir for two years. Early data showed that neither indinavir (Crixivan) nor the new version of saquinavir known as the soft gel cap (SGC) had an effect on T4 cell counts or HIV levels. The people in the study only switched their protease inhibitor, not the other anti-HIV drugs that they were taking. As a result, new Federal guidelines specify that all anti-HIV drugs should be changed when protease inhibitors are changed. The U.S. Public Health Service also recommends against using saquinavir as a first protease inhibitor because it is poorly absorbed by the body.
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PMID:Saquinavir update. 1136 16

Voluntary HIV testing of newborns is driving down the rate of maternal-fetal transmission, although mandatory testing in other populations continues to be controversial. An amendment to the Ryan White CARE Act that encourages mandatory HIV testing of newborns, to be phased in over a four-year period, is being met with resistance from AIDS activists. The justification for mandatory testing is from a single trial, ACTG 076, that shows that HIV infection rates could be decreased two-thirds in newborns through the use of AZT during pregnancy and immediately after delivery. However, there has been no testing of AZT's potential toxicity in mothers or the long-term effects on babies. This also means that AZT monotherapy, much less effective than combination therapy, is only prescribed for pregnant women. Activists call for strategy sessions and grassroots organizations to defeat the trend toward mandatory testing in any population.
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PMID:The histrionic push for mandatory perinatal HIV testing. 1136 52

The pediatric trial ACTG 300 was closed early when the data collected showed that AZT/3TC and AZT/ddI combinations were both superior to monotherapy for treating children with HIV. The original test was designed to compare differences in clinical progression in children using combination therapies, and the trial has been hailed as proving that more drugs are effective than one. A table includes data on the trial results.
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PMID:ACTG 300 leaves many questions unanswered. 1136 54

ACTG 316 is testing the effectiveness of a single dose of nevirapine (Viramune) in preventing mother-to-child HIV transmission. The drug will be given to the mother during labor, and to the infant between 48 and 72 hours after birth. This placebo-controlled study allows other drugs to be taken concurrently. Women are cautioned not to rely solely on this treatment, but to also obtain standard medical care to prevent HIV transmission. There are no CD4 or viral load requirements for entry. The test will be run in several cities; enrollment information is included. If successful, nevirapine could be an easier, safer, and less expensive treatment than AZT in preventing perinatal transmission.
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PMID:Pregnant women eligible for single-dose nevirapine study. 1136 37

Voluntary HIV testing of pregnant women and perinatal treatment with AZT have caused a decline in the rate of transmission of HIV to infants during delivery. Researchers are now looking at whether AZT in combination with other antiretrovirals will be even more effective in reducing infection rates. At the 37th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held in Toronto, researchers from the Centers for Disease Control and Prevention (CDC) reported that up to 80 percent of mothers whose HIV-positive children were identified by HIV/AIDS surveillance knew their health status before giving birth. A total of 77 percent of women received perinatal prophylaxis in 1996, compared to 36 percent in 1994. The CDC also reported a 12 percent infection rate in children who received perinatal treatment from September 1994 to December 1995, compared to 30 percent in those who received no treatment. The CDC is using this surveillance data to help States to determine how close they are to meeting the new guidelines of the Ryan White CARE Act. One requirement is to inform 95 percent of all pregnant women about their HIV status, thereby reducing perinatal infections by half. Of the new treatments being tested to reduce transmission rates, a Phase III study of nevirapine (Viramune) is the farthest along. The ACTG 316 study has begun enrolling women at 18 centers in the United States to test the non-nucleoside reverse transcriptase inhibitor. When combined with European sites, the study population should be large enough to guarantee statistical significance.
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PMID:Perinatal HIV down as treatment increases. 1136 70

Recent developments and guidelines for treating HIV-positive pregnant women and their children are reviewed. Antiretroviral therapies can be used for treating HIV infection in the mother and for preventing HIV transmission to the fetus. The clinical study ACTG 076 demonstrated that AZT successfully prevented transmission of HIV from mother to infant. Health experts are reviewing the U.S. Public Health Service recommendations that address the issue of antiretroviral treatments for infected pregnant women. The complexity of combination therapies and the lack of information about the use of many antiretroviral drugs during pregnancy makes management difficult. When making treatment decisions, physicians should consider the natural history of HIV RNA levels and the prognostic meaning of baseline HIV RNA levels in infants and children. Treatment modification guidelines that are used for adults, including poor virologic response, toxicity, sustained increase in HIV RNA copy number, and disease progression, are also useful to guide treatment for infants and children. A table is provided listing various antiretroviral agents, their Food and Drug Administration (FDA) approval status for treatment or prevention of HIV transmission, their availability in liquid form, and their placental passage properties.
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PMID:Treating the HIV-infected pregnant woman and her child. 1136 40

Results of ACTG 076, a clinical trial funded by the National Institute of Allergy and Infectious Disease (NIAID), indicate that perinatal HIV transmission rates could be significantly reduced by treating HIV-positive pregnant women with an intensive zidovudine (AZT) regimen during the second half of pregnancy and during labor and delivery, and by treating the infants for the first six weeks of life. The World Health Organization (WHO) recommended the 076 regimen and later retracted the recommendation because the regimen is unaffordable in many developing countries. As a result, NIAID is supporting clinical trials designed to identify simpler, less costly ways to prevent perinatal HIV transmission. Jack Killen, director of NIAID's Division of AIDS, responds to questions about the design of the perinatal transmission prevention studies in Uganda and Ethiopia. One Uganda study is testing the safety and pharmacokinetics of a single dose of nevirapine, and will subsequently compare this treatment with oral doses of AZT given during labor and after birth. Another Uganda study will examine passive immunization, using HIV antibodies to prevent perinatal HIV transmission. In Ethiopia, a clinical trial will compare the results of pregnant HIV-positive women who receive AZT just before delivery to those given AZT prior to giving birth and during labor and birth. The propriety and medical ethics involved in conducting placebo-controlled trials and the use of low-dose AZT are addressed. While not ideal, this research agenda for the developing world is the best hope for addressing the HIV epidemic of perinatal HIV infection.
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PMID:Preventing HIV infection in infants in developing countries: NIAID's role. National Institute of Allergy and Infectious Diseases. 1136 19

The Pediatric AIDS Clinical Trials Group (PACTG) is a national network of clinical trial sites funded by the National Institute of Child Health and Human Development and the National Institute of Allergy and Infectious Diseases (NIAID). PACTG studies, particularly ACTG 076, have been instrumental in establishing the standard of care for prevention and treatment of childhood HIV. The development of age-appropriate drugs is a fundamental challenge facing researchers in the pediatric therapeutic clinical trial arena. The differences between HIV-positive adults and children are outlined and the special developmental problems faced by HIV-infected children are described. PACTG is working to decrease the rates of HIV perinatal transmission in the U.S., achieve a 10-year survival rate for more than 90 percent of HIV-infected children, and investigate and develop early intervention strategies for infants and adolescents. To meet these goals, PACTG is conducting a number of studies: ACTG 316 examines whether nevirapine will help reduce perinatal HIV transmission, ACTG 219 will follow all children enrolled in PACTG studies until they are 18 years old, and study's ACTG 356 and ACTG 345 will examine whether early and aggressive therapy in children can alter the course of HIV disease. The Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection is available in draft format and recommends initiating combination antiretroviral therapy with potent drug regimens in all infants less than 12 months of age upon diagnosis.
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PMID:Pediatric HIV clinical trials in the United States. 1136 21


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